TMC647055 / J&J - LARVOL DELTA

Antibacterial and antibiofilm efficacy of TMC647055 against methicillin-resistant Staphylococcus aureus. (PubMed, Arch Microbiol) - "In a murine MRSA pneumonia model, TMC647055 treatment (10 mg/kg) achieved 80% survival and significantly reduced pulmonary bacterial burden, comparable to vancomycin efficacy. These findings demonstrate TMC647055 as a promising therapeutic candidate against MRSA infections, although further preclinical studies are required to confirm its potential for clinical application."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

[VIRTUAL] Computational methods applied to the discovery of SARS-CoV-2 inhibitors targeting the Spike glycoprotein (ACS-Fall 2021) - "Complete models of the Spike inserted in viral membranes were simulated using the GaMD enhanced sampling method, in the absence or presence of several copies of the top four compounds obtained from VS (phthalocyanine, hypericin, TMC-647055 and quarfloxin), to evaluate the presence of other interaction sites on the Spike surface and the ability of these molecules to insert in membranes...In parallel, molecular docking and MD simulations were also performed to evaluate the capability of bovine Lactoferrin, a glycoprotein with known antiviral properties, as a potential competitive inhibitor of Spike binding to the host cell receptor ACE2. The promising computational results obtained are also supported by in vitro evidences and by a clinical trial showing that this protein exerts a significant protective role in COVID-19 patients."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Janssen R&D Ireland; N=48 -> 24

Enrollment change • Acute Coronary Syndrome • Biosimilar • Chronic Kidney Disease • Heart Failure • Hepatitis C Virus • Immunology • Myositis

An all-oral phase IIa study combining simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated (Medivir Press Release) - P2a, N=40; "Medivir...announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845....The trial will evaluate genotype 1a and 1b HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin."

New P2a trial • Hepatitis C Virus

Broad-spectrum non-nucleoside inhibitors for caliciviruses. (PubMed, Antiviral Res) - "These NNIs included JTK-109 (RdRp inhibition range: IC50 4.3-16.6 μM), TMC-647055 (IC50 range: 18.8-45.4 μM) and Beclabuvir (IC50 range: 23.8->100 μM). Together, this study demonstrates the potential for de novo development of broad-spectrum antivirals that target the highly-conserved RdRp thumb pocket, Site-B. We also revealed three broad-spectrum HCV NNIs that could be used as antiviral scaffolds for further development against caliciviruses and other viruses."

Journal • Biosimilar • Hepatitis C Virus • Immunology • Infectious Disease

Idenix Pharmaceuticals announces initiation of phase II all-oral combination study of samatasvir (IDX719) and simeprevir (TMC435) for the treatment of hepatitis C virus (HCV) infection (Idenix) - P2, N=90; HELIX-1 (NCT01852604); Sponsor: Idenix; "Idenix ...announced the initiation of the phase II HELIX-1 clinical trial evaluating ...samatasvir (IDX719), ...and simeprevir (TMC435) ...HELIX-1 trial is a 12-week, randomized, double-blind, parallel group study evaluating the safety and tolerability of samatasvir and simeprevir ...90 treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients ...A second trial (HELIX-2) of samatasvir, simeprevir and TMC647055 ...is expected to initiate in the second half of 2013."

Anticipated new trial • Enrollment status • New P2 trial • Hepatitis C Virus

Achillion: Oppenheimer Healthcare Conference (Achillion) - Anticipated launch of simeprevir + GSK 2336805 + TMC647055/ribavirin triple combo for hep C infection in 2016/2017

Anticipated launch • Hepatitis C Virus

JNJ: Q4 & FY 2013 Results (Johnson and Johnson Ltd) - Anticipated filing of TMC647055 + JNJ56914845 + simeprevir combo in EU for hep C infection between 2014 and 2017; Anticipated filing of TMC647055 + JNJ56914845 + simeprevir combo in US for hep C infection between 2014 and 2017

Anticipated EU regulatory • Anticipated NDA • Hepatitis C Virus

Idenix: Bank of America Merrill Lynch Health Care Conference (Idenix) - Anticipated launch of IDX719 + simeprevir + TMC647055/ritonavir triple combo for genotype 1 and 4 hep C infected patients in 2016

Anticipated launch • Hepatitis C Virus